Prescription and consumption of opioids after bariatric surgery: a multicenter prospective cohort study.

INTRODUCTION: In the current opioid crisis, bariatric surgical patients are at increased risk of harms related to postoperative opioid overprescribing. This study aimed to assess the extent to which opioids prescribed at discharge after bariatric surgery are consumed by patients. METHODS: This multicenter prospective cohort study included adult patients (≥ 18yo) undergoing laparoscopic bariatric surgery. Preoperative assessments included demographics and patient-reported measures. Information regarding surgical and perioperative care interventions (including discharge prescriptions) was obtained from medical records. Self-reported opioid consumption was assessed weekly up to 30 days post-discharge. Number of opioid pills prescribed and consumed was compared using Wilcoxon signed-rank test. Zero-inflated negative binomial regression was used to identify predictors of post-discharge opioid consumption. RESULTS: We analyzed 351 patients (mean age 44 ± 11 years, BMI 45 ± 8.0 kg/m2, 77% female, 71% sleeve gastrectomy, length of stay 1.6 ± 0.6 days). The quantity of opioids prescribed at discharge (median 15 pills [IQR 15-16], 112.5 morphine milligram equivalents (MMEs) [IQR 80-112.5]) was significantly higher than patient-reported consumption (median 1 pill [IQR 0-5], 7.5 MMEs [IQR 0-37.5]) (p < 0.001). Overall, 37% of patients did not take any opioids post-discharge and 78.5% of the opioid pills prescribed were unused. Increased post-discharge opioid consumption was associated with male sex (IRR 1.54 [95%CI 1.14 to 2.07]), higher BMI (1.03 [95%CI 1.01 to 1.05]), preoperative opioid use (1.48 [95%CI 1.04 to 2.10]), current smoking (2.32 [95%CI 1.44 to 3.72]), higher PROMIS-29 depression score (1.03 [95% CI 1.01 to 1.04]), anastomotic procedures (1.33 [95%CI 1.01 to 1.75]), and number of pills prescribed (1.04 [95%CI 1.01 to 1.06]). CONCLUSION: This study supports that most opioid pills prescribed to bariatric surgery patients at discharge are not consumed. Patient and procedure-related factors may predict opioid consumption. Individualized post-discharge analgesia strategies with minimal or no opioids may be feasible and should be further investigated in future research.

Predictors of post-discharge pain and satisfaction with pain management after laparoscopic bariatric surgery: a prospective cohort study.

BACKGROUND: Pain management after bariatric surgery remains challenging given the risk for analgesia-related adverse events (e.g., opioid use disorder, marginal ulcers). Identifying modifiable factors associated with patient-reported pain outcomes may improve quality of care. We evaluated the extent to which patient and procedural factors predict 7-day post-discharge pain intensity, pain interference, and satisfaction with pain management after bariatric surgery. METHODS: This prospective cohort study included adults undergoing laparoscopic bariatric surgery at two university-affiliated hospitals and one private clinic. Preoperative assessments included demographics, Pain Catastrophizing Scale (score range 0-52), Patient Activation Measure (low [< 55.1] vs. high [≥ 55.1]), pain expectation (0-10), and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) anxiety and depression scales. At 7 days post-discharge, assessments included PROMIS-29 pain intensity (0-10) and pain interference scales (41.6-75.6), and satisfaction with pain management (high [10-9] vs. lower [8-0]). Linear and logistic regression were used to assess the association of pain outcomes with potential predictors. RESULTS: Three hundred and fifty-one patients were included (mean age = 44 ± 11 years, BMI = 45 ± 8 kg/m2, 77% female, 71% sleeve gastrectomy). At 7 days post-discharge, median (IQR) patient-reported pain intensity was 2.5 (1-5), pain interference was 55.6 (52.0-61.2), and 76% of patients reported high satisfaction with pain management. Pain intensity was predicted by preoperative anxiety (ß + 0.04 [95% CI + 0.01 to + 0.07]) and pain expectation (+ 0.15 [+ 0.05 to + 0.25]). Pain interference was predicted by preoperative anxiety (+ 0.22 [+ 0.11 to + 0.33]), pain expectation (+ 0.47 [+ 0.10 to + 0.84]), and age (- 0.09 [- 0.174 to - 0.003]). Lower satisfaction was predicted by low patient activation (OR 1.94 [1.05-3.58]), higher pain catastrophizing (1.03 [1.003-1.05]), 30-day complications (3.27 [1.14-9.38]), and age (0.97 [0.948-0.998]). CONCLUSION: Patient-related factors are important predictors of post-discharge pain outcomes after bariatric surgery. Our findings highlight the value of addressing educational, psychological, and coping strategies to improve postoperative pain outcomes.

Patients' experiences undergoing cancer surgery during the COVID-19 pandemic: a qualitative study.

PURPOSE: This study aimed to understand patients' experiences undergoing cancer surgery during the COVID-19 pandemic. In response to COVID-19, many elective cancer surgeries were delayed creating a massive backlog of cases. Patients' experiences with surgical delays may inform healthcare systems' responses to the backlog of cases and guide preparations for future healthcare emergencies. METHODS: This was a qualitative description study. Patients undergoing general surgery for cancer at two university-affiliated hospitals between March 2020 and January 2021 were invited to one-to-one interviews. Patients were purposefully selected using quota sampling until interviews produced no new information (i.e., thematic saturation). Interviews were conducted using a semi-structured guide and analyzed according to inductive thematic analysis. RESULTS: Twenty patients were included [mean age 64 ± 12.9; male (n = 10); surgical delay (n = 14); cancer sites: breast (n = 8), skin (n = 4), hepato-pancreato-biliary (n = 4), colorectal (n = 2), and gastro-esophageal (n = 2)]. When determining their willingness to undergo surgery, patients weighed the risk of COVID-19 infection against the urgency of their disease. Changes to the hospital environment (e.g., COVID-19 preventative measures) and deviations from expected treatment (e.g., alternative treatments, remote consultations, rescheduled care) caused diverse psychological responses, ranging from increased satisfaction to severe distress. Patients employed several coping strategies to mitigate distress, including eliciting reassurance from care providers, seeking information from unconventional sources, and reframing care interruptions. CONCLUSIONS: Changes in care during the pandemic elicited diverse psychological responses from patients undergoing cancer surgery. Coping was facilitated by consistent communication with providers, emphasizing the importance of patient-centered expectation setting as we prepare for the future within and beyond the pandemic.

S110-Opioid-free analgesia after outpatient general surgery: A qualitative study focused on the perspectives of patients and clinicians involved in a pilot trial.

BACKGROUND: Opioid-free analgesia (OFA) may mitigate opioid-related harms after outpatient general surgery; however, the comparative effectiveness of this approach should be assessed in robust randomized controlled trials (RCTs). Undertaking an RCT on OFA raises important practical concerns, including surgeon and patient hesitation regarding pain management without opioids. We conducted a qualitative study to explore patients' and clinicians' perspectives and experiences with a pilot trial focused on OFA after outpatient general surgery. METHODS: Patients undergoing outpatient abdominal and breast procedures were randomized to receive post-discharge opioid analgesia (OA) or OFA. Semi-structured interviews with patients and clinicians involved in the trial were conducted to elicit personal perspectives and experiences. Purposive sampling for maximum variation was used to recruit participants with diverse characteristics. Transcribed interviews were assessed using inductive thematic analysis. RESULTS: Ten patients (5 abdominal, 5 breast) and 10 clinicians (6 surgeons, 2 anesthesiologists, 2 nurses) were interviewed. Five major themes emerged: readiness for trial engagement, pre-trial thoughts about the interventions, postoperative pain experiences, intervention acceptability, and trial refinement. Most patients were open to OFA. Clinicians expressed willingness to prescribe OFA, particularly after less invasive procedures and when using peripheral nerve blocks (PNBs). Concerns were raised regarding the adequacy of pain control and side effects of non-opioid drugs (e.g., NSAID-induced bleeding, kidney injury). Overall, participants were enthusiastic about the trial and recognized its relevance; clinicians praised the study design and organization; and patients valued the use of electronic questionnaires. Suggestions for improvements included preventing potential bias arising from the use of PNBs (i.e., via standardization or stratification) and reducing patient burden (i.e., decreasing postoperative questionnaires). CONCLUSION: Patients and clinicians who participated in a pilot RCT generally accept the clinical equipoise between OA versus OFA after outpatient general surgery and recognize the need for methodologically robust trials to inform evidence-based analgesia prescribing.

Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial.

Importance: The overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain. Objective: To investigate the feasibility of conducting a full-scale randomized clinical trial (RCT) to assess the comparative effectiveness of OA vs OFA after outpatient general surgery. Design, Setting, and Participants: This parallel, 2-group, assessor-blind, pragmatic pilot RCT was conducted from January 29 to September 3, 2020 (last follow-up on October 2, 2020). at 2 university-affiliated hospitals in Montreal, Quebec, Canada. Participants were adult patients (aged ≥18 years) undergoing outpatient abdominal (ie, cholecystectomy, appendectomy, or hernia repair) or breast (ie, partial or total mastectomy) general surgical procedures. Exclusion criteria were contraindications to drugs used in the trial, preoperative opioid use, conditions that could affect assessment of outcomes, and intraoperative or early complications requiring hospitalization. Interventions: Patients were randomized 1:1 to receive OA (around-the-clock nonopioids and opioids for breakthrough pain) or OFA (around-the-clock nonopioids with increasing doses and/or addition of nonopioid medications for breakthrough pain) after postoperative discharge. Main Outcomes and Measures: Main outcomes were a priori RCT feasibility criteria (ie, rates of surgeon agreement, patient eligibility, patient consent, treatment adherence, loss to follow-up, and missing follow-up data). Secondary outcomes included pain intensity and interference, analgesic intake, 30-day unplanned health care use, and adverse events. Between-group comparison of outcomes followed the intention-to-treat principle. Results: A total of 15 surgeons were approached; all (100%; 95% CI, 78%-100%) agreed to have patients recruited and adhered to the study procedures. Rates of patient eligibility and consent were 73% (95% CI, 66%-78%) and 57% (95% CI, 49%-65%), respectively. Seventy-six patients were randomized (39 [51%] to OA and 37 [49%] to OFA) and included in the intention-to-treat analysis (mean [SD] age, 55.5 [14.5] years; 50 [66%] female); 40 (53%) underwent abdominal surgery, and 36 (47%) underwent breast surgery. Seventy-five patients (99%; 95% CI, 93%-100%) adhered to the allocated treatment; 1 patient randomly assigned to OFA received an opioid prescription. Seventeen patients (44%) randomly assigned to OA consumed opioids after discharge. Seventy-three patients (96%; 95% CI, 89%-99%) completed the 30-day follow-up. The rate of missing questionnaires was 37 of 3724 (1%; 95% CI, 0.7%-1.4%). All the a priori RCT feasibility criteria were fulfilled. Conclusions and Relevance: The findings of this pilot RCT support the feasibility of conducting a robust, full-scale RCT to inform evidence-based prescribing of analgesia after outpatient general surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04254679.

Construct validity and responsiveness of the Duke Activity Status Index (DASI) as a measure of recovery after colorectal surgery.

BACKGROUND: Returning to preoperative levels of physical function is highly valued by patients recovering from surgery. The Duke Activity Status Index (DASI, a 12-item questionnaire) may be a simple yet robust tool to assess postoperative recovery of functional capacity. This study assessed construct validity and responsiveness of the DASI as a measure of recovery after colorectal surgery. METHODS: Data from a trial on early mobilization after colorectal surgery were analyzed. Patients completed the DASI questionnaire preoperatively and at postoperative weeks (POW) 2 and 4. Construct validity was assessed by testing the primary a priori hypotheses that postoperative DASI scores (1) are higher in patients without vs with postoperative complications and (2) correlate with six-minute walk test distance (6MWD). Exploratory analyses assessed the association between DASI scores and (1) preoperative physical status [higher (ASA ≤ 2) vs lower (ASA > 2)], (2) stoma creation (no stoma vs stoma), (3) age [younger (≤ 75 years) vs older (> 75 years)], (4) time to readiness for discharge [shorter (≤ 4 days) vs longer (> 4 days)], and (5) surgical approach (laparoscopic vs open). Responsiveness was assessed by testing a priori hypotheses that DASI scores are higher (1) preoperatively vs at POW2 and (2) at POW4 vs POW2. Mean differences in DASI scores were obtained using linear regression. The association between DASI and 6MWD was assessed via Pearson correlation. RESULTS: We analyzed data from 100 patients undergoing colorectal surgery (mean age 65; 57% male; 81% laparoscopic). Mean DASI scores were 47.9 ± 12.1 preoperatively, 22.4 ± 12.7 at POW2, and 33.2 ± 15.7 at POW4. The data supported our two primary construct validity hypotheses, as well as 3/5 exploratory hypotheses. Both responsiveness hypotheses were supported. CONCLUSIONS: Our findings support that the DASI questionnaire can be a useful tool to assess postoperative recovery of functional capacity in research and clinical practice.